Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Completed · Early Phase 1

Conditions studied: Univentricular Heart

In brief

The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period. An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.

Key facts

Study ID

NCT05744934

Run by

Boston Children's Hospital

People needed

10

Starts

2023-03-15

Expected to finish

2025-12-30

Last updated by the study team

2026-05-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life

You may not qualify if…

• Prematurity (<36 weeks gestational age)
• Birth weight <2.5 kg
• Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)
• Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.
• Clinical team does not think that the patient is a good candidate

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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